Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES · Jan 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of Onabotulinum Toxin A, commonly known as Botox, as a potential treatment for swallowing difficulties caused by problems with a specific muscle in the throat called the cricopharyngeus muscle. This condition, known as transfer dysphagia, can affect people who have had strokes or have certain neurological disorders. The trial aims to gather more evidence on whether Botox injections can help relax this muscle and improve swallowing, as previous studies have been limited.

To participate in the trial, individuals must be at least 14 years old and have swallowing issues linked to their central nervous system, such as those caused by a stroke (with at least six months since the stroke occurred). Participants should be willing to undergo specific swallowing tests and follow-up visits. Importantly, they should not have other serious health conditions that could affect their eligibility or life expectancy. This study is currently recruiting participants, and those who join can expect to receive Botox injections and undergo assessments to see if their swallowing improves.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients attending neurology OPD with swallowing dysfunction due to central nervous system dysfunction
• • At least 14 years of age of all sexes
• • mRS (modified Rankin scale) of ≤3 at time of study enrolment
• • In case of post stroke dysphagia, at least 6 months have passed following stroke
• • Willing to undergo swallowing assessment clinically and with video fluoroscopy, flexible upper GI endoscopy and esophageal manometry before and after the injection
• • Above investigations show impaired cricopharyngeal relaxation, adequate pharyngeal strength and anterocephalad laryngeal movement
• • Ready to provide consent for Botulinum neurotoxin injection.
• • Willing to adhere to protocol and comply with follow up visits
• • No major neurologic or systemic medical condition that reduces life expectancy to less than 1 year based on clinical prediction scores
• Exclusion Criteria:
• • Diagnosed cases of neuromuscular disorders of the peripheral nervous system and ALS
• • mRS at time of enrolment \>3
• • Patients with expected life expectancy less than 1 year due to primary disease or co morbidity based on clinical prediction scores
• • Known allergy to botulinum neurotoxin or its preservatives/excipients
• • Received botulinum toxin for any indication in the last 12 weeks
• • Those with known antibodies against Botulinum neurotoxin A
• • Those who underwent myotomy of the cricopharyngeus muscle
• • Those who had undergone procedures like denervation of the cervical musculature
• • Dysphagia of other causes not fulfilling inclusion criteria
• • Women of childbearing potential who are not using adequate contraception or who are pregnant and lactating
• • Not willing to provide consent